Overview

Dose Titration of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension

Status:
Completed
Trial end date:
2018-09-17
Target enrollment:
0
Participant gender:
All
Summary
This open label 4 month study will evaluate efficacy (blood pressure lowering effects) and safety of lisinopril in children 1-18y whose parents grant permission to participate. This dose titration study is being conducted to support the statement that personalized titration of lisinopril (based on blood pressure and renin-aldosterone ratio) can increase patient response.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Ghent
Treatments:
Angiotensin-Converting Enzyme Inhibitors
Lisinopril
Criteria
Inclusion Criteria:

- Parental consent must be granted

- Patient age: 1y - 18 y

- Documented diagnosis of hypertension as defined in the National Heart, Lung and Blood
Institute (NHBLI) 4th report, 2004

- No reversible cause found on diagnostic work-up for hypertension

- Children older than 6y: 24h blood pressure monitoring confirms the diagnosis of
hypertension

Exclusion Criteria:

- Pregnancy

- Sexually active girls can only be included in the trial if they use an adequate form
of birth control; during and until 30 days after ending the trial

- Following abnormal laboratory values: Hyperkaliemia (serum potassium > 5.3mmol/L);
Anemia (hemoglobin < 8g/dL); AST or ALT > 3 times the upper limit of reference range;
Total bilirubin > 3 times the upper limit of reference range

- Abnormalities of the oral cavity that can influence intake of medication

- Known sensitivity to ACE-inhibitors

- Known lactose intolerance

- History of angioedema

- Unilateral or bilateral stenosis of the renal artery

- Diagnosis of heart failure (NYHA Class II-IV)

- History of coarctation of the aorta

- Current treatment with: other drugs influencing the renin-angiotensin-aldosterone
system; lithium; potassium sparing diuretics; non-steroidal anti-inflammatory drugs;
aspirin; oral antidiabetic medication